Atlas FDA

CONNECT DATA MANAGEMENT SYSTEM

FDA 510(k) clearance K994433 · decided 2000-05-05

Clearance details

K-number
K994433
Device name
CONNECT DATA MANAGEMENT SYSTEM
Applicant
Abbott Diabetes Care, Inc.
Decision
Substantially Equivalent
Date received
1999-12-30
Decision date
2000-05-05
Days to decision
127 days
Clearance type
Traditional
Product code
LFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Alameda, CA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (K131366)Roche Diagnostics Operations, Inc.2013-10-11
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (K122688)Nova Biomedical Corporation2013-04-04
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS (K121433)Hmd Biomedical, Inc.2013-02-14
NOVA ONE BLOOD GLUCOSE MONITOR (K122435)Nova Biomedical Corporation2012-12-20
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (K113314)Hmd Biomedical, Inc.2012-11-09
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (K121224)Taidoc Technology Corporation2012-09-19
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (K113307)Hmd Biomedical, Inc.2012-07-27
CONTOUR NEXT BLOOD GLUCOSE METER (K121190)Bayer Healthcare, LLC2012-07-26

Recalls involving this device

RecordFirmDate
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Managemen recall (Z-1594-05)Abbott Diabetes Care, Inc.2005-10-01

PMA approvals by this applicant

RecordFirmDate
FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S057)Abbott Diabetes Care, Inc.2025-07-11
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S060)Abbott Diabetes Care, Inc.2025-07-11
FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S056)Abbott Diabetes Care, Inc.2024-04-05
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S059)Abbott Diabetes Care, Inc.2023-11-21
FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S055)Abbott Diabetes Care, Inc.2023-11-21
FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S058)Abbott Diabetes Care, Inc.2023-06-30
FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S053)Abbott Diabetes Care, Inc.2023-06-30
FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S052)Abbott Diabetes Care, Inc.2023-01-17